Position Summary:

The Executive Director, Regulatory Affairs will be responsible for providing strategic leadership and direction for all clinical, development, and operational regulatory activities within Zenas Biopharma. We are seeking a results-oriented leader who will be responsible for developing and implementing comprehensive regulatory strategies to ensure timely and successful interactions with global health authorities. This role entails overseeing regulatory compliance, submissions, and documentation processes while ensuring alignment with applicable laws, regulations, and industry standards. Additionally, you will lead a team of regulatory affairs and operations individuals fostering a culture of excellence, collaboration, and innovation. This position reports to the SVP, Global Regulatory Affairs and Medical Writing.

Key Responsibilities: 

• Oversee regulatory affairs team and support the planning and execution of strategic plans for regulatory affairs to support business objectives and regulatory compliance.
• Provide guidance and insight to senior management on regulatory trends, risks, and opportunities impacting the organization.
• Ensure compliance with global regulatory requirements, including FDA regulations, EMA guidelines, and other relevant standards.
• Oversee the preparation and submission of regulatory documents, such as INDs, NDAs, BLAs, and marketing authorization applications (MAAs).
• Manage interactions with regulatory agencies, including pre-submission meetings, regulatory submissions, and responses to inquiries.
• Provide oversight and guidance on the development of regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions.
• Collaborate with cross-functional teams, including clinical development, quality assurance, pharmacovigilance, and legal, to ensure alignment of regulatory strategies, activities and compliance.
• Contributes to the development of the overall strategy and goals of the regulatory function.
• Management of regulatory budget and vendors for projects associated with regulatory team.
• Provide mentoring, coaching, and performance feedback to team members to foster professional growth and development.
• Embodies a solution-oriented work style where challenges are embraced, and problem solving/issue resolution is prioritized.
• Embraces change as an opportunity to grow and develop.

Qualifications: 

• Bachelor’s Degree required; advanced degree preferred 
• Minimum of 12+ years Global Regulatory experience in a biotech/pharma environment with at least 3 years as functional head of Regulatory
• Experience in early, late and commercial stage biopharma companies
• Experience leading a successful BLA/NDA submissions globally
• Strong abilities in coaching, communicating, leading, managing and inspiring within organizations
• Excellent oral and written communication skills. Able to collaborate effectively cross-functionally and build effective relationships with external partners, suppliers and industry organizations 

#LI-Hybrid 

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $229,600 to $287,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.